BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA

    MDR report key: 1981064 · Received February 8, 2011

    Report

    Report Number
    2647346-2011-00080
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 16, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2010. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(4) 2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 2011 AND REVEALED PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A FAMILY MEMBER OF THE PATIENT THAT THEY WERE CONCERNED THAT THE DEVICE, A TRIPLE-CHAMBER IMPLANTABLE DEFIBRILLATOR, "MAY NOT BE FUNCTIONING" AND REQUESTED THAT THE DEVICE BE CHECKED. FAMILY MEMBER FURTHER REPORTED PATIENT WAS A HOSPITAL INPATIENT AT THE TIME OF THE REPORT AND NEARING DEATH. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED. THE CAUSE OF DEATH IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| H| L| R